Kornimate/medical-research-clean huggingface dataset:
study to evaluate the efficacy and safety of oxabact (oc5) in patients with primary hyperoxaluria

Conditions: Primary Hyperoxaluria

Summary: the purpose of this study is to determine if oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.


Eligibility criteria:
inclusion criteria: * signed informed consent (as applicable for the age of the subject). * male or female subjects ≥ 2 years of age (germany \& france) / male or female subjects ≥ 5 years of age (united kingdom) * a diagnosis of ph type i, ii or iii (as determined by standard diagnostic methods). * a mean urinary oxalate excretion of \> 1.0 mmol/24h/1.73m2, based on at least three eligible urine collections performed during baseline (weeks 1-4). * renal function defined as an estimated gfr ≥ 40 ml/min normalised to 1.73m2 body surface area, or a creatinine clearance of ≥ 40 ml/min normalised to 1.73m2 body surface area. * subjects receiving vitamin b6 must be receiving a stable dose for at least 3 months prior to screening and must not change the dose during the study. subjects not receiving vitamin b6 at study entry must be willing to refrain from initiating pyridoxine during study participation. exclusion criteria: * inability to collect complete 24-hour urine samples. each urine collection will be evaluated for completeness based on urine qualitative criteria. * inability to swallow size 4 capsules twice daily for 8 to 10 weeks. * subjects that have undergone transplantation (solid organ or bone marrow). * the existence of secondary hyperoxaluria, e.g. hyperoxaluria due to bariatric surgery or chronic gastrointestinal diseases such as cystic fibrosis, chronic inflammatory bowel disease and short-bowel syndrome. * use of antibiotics to which o. formigenes is sensitive, including chronic use, a history of more than two courses of antibiotic use during the past 6 months, current antibiotic use, or antibiotics use within 14 days of initiating study medication. * subjects who require immune suppressive therapy. * current treatment with ascorbic acid preparation. * pregnancy. * women of child-bearing potential who are not using adequate contraceptive precautions such as oral, transdermal, injectable, or implanted contraceptives, iud, complete abstinence, use of a condom by the sexual partner, or sterile sexual partner. * presence of a medical condition that the principal investigator considers likely to make the subject susceptible to adverse effect of study treatment or unable to follow study procedures. * participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to screening or not willing to forego other forms of investigational treatment during this study.

Keywords: hyperoxaluria oxalate ph
intravitreal ketorolac for chronic uveitis: a investigational safety study

Conditions: Inflammation

Summary: intraocular delivery of ketorolac will be an effective means to treat inflammation and macular edema and prevent structural complications and vision loss in patients with uveitis who are unable to tolerate corticosteroids due to their side effects.

a phase i safety study of intravitreal ketorolac in patients with chronic inflammation and complications due to inflammation who have either failed medical therapy or who cannot tolerate corticosteroids due to side effects. specific aims 1. test the safety of intraocular injection of 4mg of ketorolac in patients who have intractable uveitis or complications of uveitis such as chronic macular edema who are unable to tolerate corticosteroids due to their side effects. 2. test the efficacy of intraocular 4m ketorolac of treating inflammation or structural complications of inflammation in patients with uveitis who are unable to tolerate corticosteroids due to their side effects.

Eligibility criteria:
inclusion criteria: * adult volunteers * chronic intractable uveitis or chronic complications of uveitis (macular edema)despite maximal medical treatment * unable to tolerate corticosteroids due to side effects exclusion criteria: * 18 years or younger * have active ocular infection * pregnancy

Keywords: inflammation macular edema
cochlear implant pda based research platform

Conditions: Hearing Impaired

Summary: the primary purpose of the research is to study how individuals who wear cochlear implants process sounds in noisy environments and also whether newly designed programs can help improve the communicative ability of cochlear implant patients in noisy situations.

cochlear implants have been successful in restoring partial hearing to profoundly deaf people. despite their success, most implant patients are not able to communicate in noisy environments (e.g., in a restaurant). communicating in noise still remains one of the biggest challenges in cochlear implants. little is known about the factors that contribute to the poor performance of ci users in noise. in this project, we propose a series of experiments aimed at isolating these factors. we propose new programs that can be tailored for noisy situations.

Eligibility criteria:
inclusion criteria: 1. post-lingually deafened adults: * 18 years of age or older * unilateral or bilateral nucleus implant users (this includes all three generations of the nucleus system, i.e., ci22, ci24 and ci24r). * with or without residual hearing in the contralateral ear. subjects may use amplification (hearing aid) in the opposite or same ear as the implant. * a minimum test score of 30% in tape-recorded open-set sentence recognition scores (e.g., spondee identification). * minimum of 6 months experience with their implant device. this is done to ensure that all patients are familiar with the hearing sensations perceived by a cochlear implant. * minimum number of active electrodes: 10 * minimum number of subjects for each test site: 5 2. prelingually and perilingually deafened adults: * 18 years of age or older * unilateral or bilateral nucleus implant users. * with or without residual hearing in the contralateral ear. subjects may use amplification (hearing aid) in the opposite or same ear as the implant. * a minimum test score of 10% in tape-recorded open-set sentence recognition scores (e.g., spondee identification). * minimum of 6 months experience with their implant device. this is done to ensure that all patients are familiar with the hearing sensations perceived by a cochlear implant. * minimum number of active electrodes: 10 * minimum number of subjects for each test site: 5 exclusion criteria: * non-english speaking * hearing loss of neural or central origin * absence of cochlear or viii nerve development * the presence of systemic condition which would preclude use of a cochlear implant * active middle ear infection/tympanic membrane perforation * significantly abnormal cognitive function, as determined by case history information and/or clinical observations * significant psychiatric disorder, as determined by case history information and/or clinical observations

Keywords: cochlear implants
clinical study of merlin's divert - vascular reconstruction device and delivery system

Conditions: Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion

Summary: the objective of the proposed investigation is to assess the safety and effectiveness of the merlin's divert system for the treatment of intracranial lesions. merlin is a manufacturer of flow- diverters (fd) for neurovascular applications. the technology is based on a microporous polymer membrane which is delivered to the site of lesion treatment using a metal stent scaffold. the first device in its fd family is the xcalibur aneurysm occlusion device (aod) system, which is delivered on a rapid-exchange balloon catheter which goes in a 6-fr guide-catheter. the aod is ce-marked and has been involved in the treatment of over 70 clinical lesion/aneurysm cases. the same technology is now being made available in a self-expandable stent platform delivered on a 0.028" microcatheter. merlin has performed the required in-silico, in-vitro and in-vivo tests to be confident of the device performance and now intends to proceed to the human clinical-trials. divert (interventional) is a non ce mark device. the device is under clinical trial phase. the competent authority submission for the study has been completed in spain, turkey and hungary.

the study will recruit patients with intracranial aneurysm (ia) or a lesion located in the anterior or posterior circulation. the analyses of the data from this safety and feasibility study will be descriptive.

Eligibility criteria:
inclusion criteria: * subject has provided written informed consent using the irb/ec-approved consent form and agrees to comply with protocol requirements. * age 18-80 years. * subject has a target intracranial aneurysm (ia) or a lesion located in the anterior or posterior circulation. * subject has a target ia with a wide or large neck aneurysm or a lesion. the aneurysm type includes saccular, fusiform, dissecting or blister shapes. exclusion criteria: * major surgery in the last 30 days. * history of irreversible bleeding disorder and/or subject presents with signs of active bleeding. * nih stroke scale ( nihss) greater than or equal to 4 * any known contraindication to treatment with flow diverters. * pregnant women. * participating in another clinical trial.
a randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel plus or minus sorafenib (bay 43-9006) in chemonaive patients with stage iiib-iv non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small Cell Lung

Summary: a randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel plus or minus sorafenib in chemonaive patients with stage iii-iv non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * stage iiib (with effusion) or stage iv nsclc any histology * no prior chemotherapy * eastern cooperative oncology group (ecog) performance status of 0 or 1 * greater than or equal to 18 years of age * life expectancy at least 12 weeks * adequate bone marrow, liver and renal function exclusion criteria: * prior systemic anti cancer therapy * known brain metastasis. patients with neurological symptoms should undergo at computed tomography (ct) scan/magnetic resonance imaging (mri) of the brain to exclude brain metastasis * pulmonary hemorrhage/bleeding event \> common terminology criteria for adverse events (ctcae) grade 2 within 4 weeks of first dose of study drug * thrombotic or embolic events including transient ischemic attack (tia) within the past 6 months * uncontrolled hypertension * any other hemorrhage/bleeding event \> ctcae grade 3 within 4 weeks of first dose of study drug * major surgery within 4 weeks * evidence or history of bleeding diathesis or coagulopathy

Keywords: non-small cell lung cancer nsclc
a study to evaluate mezigdomide, bortezomib and dexamethasone (mezivd) versus pomalidomide, bortezomib and dexamethasone (pvd) in participants with relapsed or refractory multiple myeloma (rrmm)

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: the purpose of this study is to compare the efficacy and safety of mezigdomide (cc-92480), bortezomib and dexamethasone (mezivd) versus pomalidomide, bortezomib and dexamethasone (pvd) in participants with relapsed or refractory multiple myeloma (rrmm) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.


Eligibility criteria:
inclusion criteria - participant has documented diagnosis of mm and measurable disease, defined as any of the following:. i) m-protein ≥ 0.5 grams per deciliter (g/dl) by serum protein electrophoresis (spep) or. ii) m-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (upep). iii) for participants without measurable disease in spep or upep: serum free light chain (sflc) levels \> 100 mg/l (10 mg/dl) involved light chain and an abnormal kappa/lambda flc ratio. * participants received 1 to 3 prior lines of antimyeloma therapy. * participants achieved minimal response \[mr\] or better to at least 1 prior antimyeloma therapy. exclusion criteria - participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:. i) subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded. ii) participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded. * for participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (mr) or better, or participant discontinued bortezomib due to toxicity. * participant has had prior treatment with mezigdomide or pomalidomide. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: multiple myeloma rrmm mezivd pvd cc92480 pomalidomide bortezomib dexamethasone mezigdomide
to investigate the safety and tolerability of repeated subcutaneous injections of cad106 in alzheimer's patients

Conditions: Alzheimer Disease

Summary: this study will investigate the safety and tolerability of repeated subcutaneous injections of cad106 in alzheimer's patients.


Eligibility criteria:
inclusion criteria: * patients who have completed the core study with no significant safety concerns exclusion criteria: * diagnosis of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression). * diagnosis or presence of an active, uncontrolled seizure disorder and/or cerebrovascular disease. * diagnosis or presence of an active autoimmune and/or with an acute or chronic inflammation. other protocol-defined inclusion/exclusion criteria may apply

Keywords: active immunization alzheimer disease antibody central nervous system diseases neurodegenerative diseases vaccine
decitabine, venetoclax and blinatumomab for maintenance following hsct in patients with ph-negative b-all

Conditions: B-cell Acute Lymphoblastic Leukemia

Summary: this study aims to evaluate whether maintenance therapy with decitabine, venetoclax and blinatumomab could improve the 2-year progression free survival (pfs) of patients with philadelphia chromosome-negative b-cell acute lymphoblastic leukemia who had recently received an allogeneic stem cell transplant and in measurable residual disease-negative remission.

this is a phase ⅱ, open-label, single-arm, multi-center study in patients with philadelphia chromosome-negative b-cell acute lymphoblastic leukemia who had recently received an allogeneic stem cell transplant and in minimal residual disease-negative remission. in this study, patients will be treated with 4 cycles of maintence therapies for up to one year (or until intolerable toxicity, death, withdrawal, or study termination). in cycle one and three, patients will receive decitabine monotherapy, and in cycle two and four, patients will receive a combination of venetoclax and blinatumomab. this study aims to evaluate whether maintenance therapy with decitabine, venetoclax and blinatumomab could improve the 2-year progression free survival (pfs) of those patients, and explore the efficiency and safety.

Eligibility criteria:
inclusion criteria: * 1.philadelphia chromosome-negative b-cell acute lymphoblastic leukemia who underwent an allohsct as follows: 1. patients in cr1 with high-risk features,including adverse clinical features, cytogenetic or molecular alterations according to nccn 2023.v3. 2. patients lack of achievement of complete remission after standard induction chemotherapy. 3. patients with detectable minimal residual disease pre-transplantation. 4. patients in second and higher cr pre-transplantation. 2.negative minimal residual disease prior to enrollment (fcm-mrd \<0.01% and fusion gene negative). 3.≥3 months post-transplantation. 4.hematopoietic reconstitution, i.e., anc ≥0.5 x 109/l, and platelets \>20 x 109/l. 5.eastern cooperative oncology group (ecog) score: 0-2. 6.total serum bilirubin ≤ 3 x upper limit of normal (uln), alanine aminotransferase (alt) ≤ 5 x uln, aspartate aminotransferase (ast) ≤ 5 x uln. 7.creatinine clearance ≥ 30 ml/min. 8.provide informed consent. exclusion criteria: * 1.patients with another malignant disease. 2.patients with uncontrolled active infection. 3.patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade iii/iv cardiovascular dysfunction according to the new york heart association classification. 4.detectable minimal residual disease post-transplantation 5.active gvhd requiring systemic steroid therapy. 6.patients with uncontrolled active bleeding. 7.pregnant and lactating women; patients of childbearing potential should be willing to practice methods of contraception throughout the study period. 8.patients with other commodities that the investigators considered not suitable for the enrollment.

Keywords: ph-negative b-all hsct maintenance therapy
technology and health communication in improving health outcomes in patients scheduled for mammography

Conditions: Female Breast Carcinoma; Healthy Subject

Summary: this pilot clinical trial studies how well technology and health communication works in improving health outcomes in patients scheduled for mammography screening. the mobile mammography screening program provides a vital health service and it is important that all women scheduled for an appointment show-up to be screened. technology and health communication may help decrease no-show rates among patients scheduled for mammography screening.

primary objectives: i. to decrease the mobile mammography unit no-show rate by sending text message appointment reminders to patients. ii. to assess the efficacy of the text message reminders at addressing the no-show rate by collecting satisfaction survey data from patients that received the texts and that came to their scheduled appointment. outline: patients receive 1-2 text messages a few weeks before and 1 text message 24 hours before their mammography screening appointment. patients also receive a phone call reminder as per standard practice.

Eligibility criteria:
inclusion criteria: * appointment is at a participating location * has a cell phone that can send and receive text messages * agrees to receive the text messages * can read either english or spanish * not yet sent text messages to 100 patients in community or corporate sites * scheduled at least 1 week prior to the appointment date * patients for follow up: come to their scheduled appointment * patients for follow up: received the text message reminders * patients for follow up: can read either english or spanish
costar catheter system evaluation

Conditions: Symptomatic Ischemic Heart Disease

Summary: to evaluate product performance and safety of the catheter design for the treatment of a single coronary lesion.


Eligibility criteria:
inclusion criteria: 1. patient is ≥18 years of age. 2. eligible for percutaneous coronary intervention (pci). 3. documented stable or unstable angina pectoris (canadian cardiovascular society classification \[ccs\] 1, 2, 3, or 4), documented ischemia, or documented silent ischemia. 4. left ventricular ejection fraction (lvef) ≥25% documented within the last 6 weeks. 5. acceptable candidate for coronary artery bypass graft surgery (cabg). 6. patient understands the study requirements and the treatment procedures and provides written informed consent using a form that has been approved by the local institutional review board or ethics committee before any study-specific tests or procedures are performed. 7. willing to comply with all specified follow-up evaluations. inclusion criteria (angiographic): 1. a single de novo lesion per study subject may be treated with the study device. 2. each target lesion may be composed of multiple lesions but must be completely coverable by one (1) study stent. 3. cumulative target lesion length per vessel is ≤24 mm based on a visual estimate. 4. rvd of ≥2.5 mm to ≤3.0 mm based on a visual estimate. 5. target lesion diameter stenosis ≥50% and \<100% based on a visual estimate. 6. target vessel has not undergone prior revascularization within the preceding 6 months. 7. target lesion must be a minimum of 10 mm distance from any previously treated segment of the target vessel exclusion criteria: 1. known sensitivity to cobalt chromium, paclitaxel or polymeric matrices: plga. 2. planned treatment with any other pci device in the target vessel(s). 3. acute mi within 72 hours prior to the index procedure as defined by the presence of a new pathologic q wave, or creatinine kinase (ck) \>2 times the laboratory upper limits of normal and elevated mb. 4. the patient is in cardiogenic shock. 5. cerebrovascular accident (cva) within the past 6 months. 6. acute or chronic renal dysfunction (creatinine \>2.0 mg/dl or \>150 µmol/l). 7. contraindication to asa or to clopidogrel. 8. thrombocytopenia (platelet count \<100, 000/mm3). 9. active gastrointestinal (gi) bleeding within the past three months. 10. any prior true anaphylactic reaction to contrast agents.
level of agreement between clinical defocus curves and the web-based democritus digital acuity reading test wddart

Conditions: Presbyopia; Near Vision

Summary: the primary objective of this study is to compare the level of agreement between clinical defocus curves and the web democritus digital acuity reading test (wddart), which is a web-based digital near and intermediate vision reading test.

the 'defocus curve' assessment technique aims to simulate different distances from near to far over which the patient's visual acuity (va) is evaluated. defocus curves are created by first measuring best-corrected distance and near va of the examinee. then, a series of positive- and negative-powered trial lenses are added to the best-corrected distance visual acuity (bcdva) of the patient's eye. viewing through the addition of a minus lens creates divergent light rays with the same refractive effect as bringing the eye chart closer to the viewer. for instance, a -2.50 d lens represents the distance of 40 cm. the "defocus curve" assessment technique is a method used widely for the assessment of the functional vision range following multifocal intraocular lens (iol) implantation. since this method is a simulation of the near vision, it would be ideal if near vision could be evaluated objectively with a near vision chart. however, the conventional printed near vision charts are not available for a variety of reading distances. in addition, the measurement of near va at different distances with a printed reading chart intended for one predefined distance (e.g. printed chart for 40 cm) and the transformation of the reading score at 40 cm to an equivalent score for the examined distances is impractical in clinical setting. for this reason, a digital reading test that allows the text calibration for all reading distances could be a practical method for the rapid and ease evaluation of the near va, especially in patients implanted with multifocal iols. the web-based digital near and intermediate vision reading test wddart offers the ability to estimate va at different distances with automated measurement of the patient-screen distance. therefore, the present study aims to investigate the level of agreement between clinical defocus curves and the web-based digital near and intermediate vision reading test wddart.

Eligibility criteria:
inclusion criteria: * previous cataract lens extraction, age\> 40 years, monocular best corrected distance visual acuity \> 7/10 exclusion criteria: * glaucoma, corneal diseases, macular diseases, postoperative opacification of the posterior capsule, former mental diseases

Keywords: defocus curves multifocal iol implantation wddart